All,Site ID is an important term, but it's not required for every document / content item in the eTMF - this maps to the TMF RM.As a term from the eTMF domain metadata class, Site ID is already included in metadata (as can be seen from previous meeting slides).Since the term Site ID is part of the eTMF domain, and, since its not 'Required' for system core technology/architecture, addressing details of this term should be addressed in the Phase 2 eTMF domain term discussions, as per the TC charter.1-What are Required metadata terms?Required MD terms must be applied to EVERY document/content item in the eTMF and must have a value. For the eTMF domain class, REQUIRED terms are marked in the table with a red asterisk*.2-What is core metadata?Core metadata is the essential, concise and most minimal set of metadata that's needed to characterize the core system as modeled without any specific domain metadata. To enable system interoperability, less 'required' metadata is better than more.>We did approve adding the concept/term 'Sponsor' to all eTMF content, but this is a 'Required' term, and it applies to all content in the eTMF. Site ID doesn't however apply to all content in the eTMF, only to selected documents/items. Therefore it should not be considered as 'Required' MD in Phase 1.On Tue, Feb 11, 2014 at 11:58 AM, O'Keefe, James <jokeefe@consultparagon.com> wrote:
The vast majority of studies have multiple sites
Sent from my iPhoneIn this context, what is the impact if a study has multiple sites? This seems very much a possibility.
Mead
From: etmf@lists.oasis-open.org [mailto:etmf@lists.oasis-open.org] On Behalf Of Eldin Rammell, Rammell Consulting
Sent: Tuesday, February 11, 2014 5:53 AM
To: 'Zack Schmidt'
Cc: etmf@lists.oasis-open.org
Subject: RE: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded
Hi Zack,
Please include Site ID as a specific metadata discussion item for our next meeting too. Site ID is critical to data exchange for site-level documents as personnel at the site (including PI) can and do frequently change. Site ID is the one attribute that remains constant to ensure site-level documents get associated with the correct site within a TMF. This is also critical for data exchange/interoperability. The exchange of site-level TMF content from one eTMF to another eTMF only requires Site ID to ensure correct site association. For this reason, I think it should be included as core metadata. PI name, role and organization is secondary metadata that is typically maintained in a CTMS. It is only core when considering documents such as CVs, signature pages etc where you need to capture the identity of the person to whom the document relates.
Thanks.
Kind regards,
Eldin.
Eldin Rammell
Managing Director, RAMMELL Consulting Ltd
Office: +44 (0)844 8844926 Direct dial: +44 (0)1905 617 716 Mobile: +44 (0)7940 859721
From: etmf@lists.oasis-open.org [mailto:etmf@lists.oasis-open.org] On Behalf Of Zack Schmidt
Sent: 11 February 2014 01:08
To: etmf@lists.oasis-open.org
Subject: [etmf] Groups - eTMF Std - Content Classification Layer Summary uploaded
Submitter's message
Slides for Mon Feb 17 9-10am PST TC meeting. Summary of content classification layer in architecture. Most of the content in the slides recaps our discussions/motions.
New items for continued discussion addresses TC comments re: Sponsor, Country, Created By terms and versioning. There are several metadata terms which we need to vote on: Clinical Trial Sponsor vs. Sponsor; Document Version vs. Content Item Version. We can cover this in the meeting.
Ideally we will be ready to make a motion to adopt the Content Classification Layer at the next meeting. Note that we can go back and make minor adjustments/fixes to the spec at a later time if needed.
Please review prior to our next meeting.
- Thanks, Zack Schmidt
-- Mr. Zack Schmidt
Document Name: eTMF Std - Content Classification Layer Summary
Description
Core Metadata, Content Model format/exchange
Download Latest Revision
Public Download Link
Submitter: Mr. Zack Schmidt
Group: OASIS Electronic Trial Master File (eTMF) Standard TC
Folder: Documents
Date submitted: 2014-02-10 17:08:05
--
Zack Schmidt, President
SureClinicalHealthscience Applications
2865 Sunrise Blvd Suite 218
Rancho Cordova, CA 95742zs@SureClinical.netSupport: 916-265-2000Direct: 916-265-2004
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